Menú

Brain Connectivity in Depression

Overview

This study will include 60 subjects with medication-refractory depression undergoing transcranial magnetic stimulation (TMS) to the left dorsal lateral prefrontal cortex (DLPFC). In order to obtain good quality data and account for attrition, 80 subjects will be recruited. Subjects will be recruited from the Clinical Program of FDA approved TMS at the Berenson-Allen Center and the Butler TMS Clinic (40 per site). Subjects will undergo an hour-long MRI scanning session, an optional DNA-sample collection, up to three 20 minute neuronavigation sessions for marking the site of TMS stimulation, questionnaires, and a behavioral testing battery before and after their TMS treatment course. The task battery will last 45-60 minutes and consist of the Emotion Conflict Resolution (ECR) task, Multi-Source Interference Task (MSIT), War Game (Gambling) task, and Associative Learning with Reversal task. Subjects’ scores on the Hamilton Depression Rating Scale (HDRS) and Beck Depression Inventory (BDI) will also be assessed before and after the TMS course. MRI data will be utilized to identify brain regions whose connectivity to the stimulation site co-varies with the aforementioned objective measures of symptom improvement.

Full Title of Study: “Using Human Brain Connectivity to Identify the Causal Neuroanatomical Substrate of Depression Symptoms”

Study Type

Study Type: Interventional

Study Design

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Study Primary Completion Date: October 31, 2022

Interventions

Other: MRI scan and behavioral testing

Patients will undergo an MRI scan and behavioral testing

Arms, Groups and Cohorts

Experimental: MRI and behavioral assessment

Subjects will undergo an hour-long MRI scanning session, a marking for the site of planned clinical TMS stimulation and a behavioral testing battery before and after their TMS treatment course.

Clinical Trial Outcome Measures

Primary Measures

Prediction of rTMS clinical response

Time Frame: 1 year after study completion

Connectivity between each patient’s stimulation site and the subgenual cingulate will be used to predict clinical response to rTMS

Participating in This Clinical Trial

Inclusion Criteria

1. Male or female

2. Aged 18-70.

3. Have previously received or will receive TMS to the left dorsal-lateral prefrontal cortex as part of the clinical treatment program at the Berenson-Allen Center for Non-invasive Brain Stimulation or the Psychiatric Neurotherapeutics program at McLean Hospital for treatment of medication resistant depression

Exclusion Criteria

1. Any current or past history of a major psychiatric illness other than depression (e.g. bipolar affective disorder, schizophrenia, obsessive compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder)

2. Any significant current neurological illness (e.g. a history of seizures or unexplained loss of consciousness, a family history of epilepsy, signs of increased intracranial pressure, previously abnormal MRI scans, parkinsonism or dementia). Of note, most of these are also contraindications to receiving TMS and these patients would not be enrolled in the clinical treatment program.